Insights On Quality Assurance

1. Progress In LC-MS-Based Metabolomics Techniques 5/2/2022

   Get updated on recent advances in metabolomics analysis by mass spectrometry (MS) with this introduction to approaches and technologies.

2. Speed To Market – API Large Scale Commercial Manufacturing 1/20/2022

   A pharmaceutical company was looking to partner with a CMO with commercial manufacturing capabilities, large scale assets, multinational sites and exemplary quality systems/US FDA track record.

3. How A Robust Manufacturing Software Solution Can Reduce The Frequency And Impact Of Deviations 3/22/2022

   Read how to leverage manufacturing software with robust digital tools to increase operational visibility and stay on top of deviations so that they don’t turn into corrective/preventive actions (CAPAs), or worse.

4. Our Biotech Success - Surrozen 4/13/2022

   Surrozen was keen to get started on process development and manufacturing and needed a CDMO with experience developing and producing bispecific antibodies and fusion proteins.

5. Why Don’t OEM Recommendations Work For Maintenance? 12/22/2020

   Understand why manufacturer recommendations fail, the concept of risk-based maintenance strategy, and how your organization can optimize your assets’ performance.

6. A Guide To Pharmaceutical Quality Management 6/16/2022

   Despite the inherent challenges of connecting quality and compliance data, there are tools that can help you to ensure quality's connectedness and central bearing. 

7. Supplier Quality Agreements 101: What, Who, And Why? 9/14/2021

   Quality agreements with suppliers can go a long way to demonstrating the kinds of control that medical device manufacturers have over their suppliers.

8. Quality With Clarity: Bringing Modern Quality Systems Into Focus 8/24/2021

   Modern pharmaceutical regulatory and manufacturing models have made great advances assuring and confirming quality of products for all of us. The further industry moves from the initial application of the early practices and subsequent systems, the more challenging it has become to differentiate between the many facets of quality concepts. The intent of this white paper is to clarify those concepts and bring their fundamentals into focus.

9. Successful Control Strategies – Part 2 1/24/2022

   Explore the importance of fate and purge studies, which measure the ability of the process to remove impurities and provide evidence of their removal.

10. The 4 Phases Of CAPA Maturity: A Guide To Mastering Quality Event Management 6/22/2022

    This brief provides an understanding of the key role corrective actions/preventive actions (CAPAs) serve in regulatory compliance and product quality improvement and offers a blueprint to help develop your own effective and optimized strategies.